Kornimate/medical-research-clean huggingface dataset:
clinical evaluation of hpt treated rigid contact lenses made from hexafocon a

Conditions: Ametropia

Summary: this will be an up to six months, subject-masked, contralateral, parallel-group, randomised, daily wear study. all subjects will wear the test lens in one eye and the control lens in the other eye. data from the first four weeks of test and control lens exposure will be used for the fda 510 (k) submission.


Eligibility criteria:
inclusion criteria: * willing and able to sign the informed consent form * aged ≥18 years old * experienced wearer of rigid gas permeable contact lenses * subject's habitual contact lenses must be made of boston xo (hexafocon a) material * subjects must have owned spectacles or contact lenses prior to enrolment for this trial * spherical power between -10.00 d and +10.00 d (at vertex distance 0 mm) * corneal astigmatism ≤2.00 d exclusion criteria: * eye injury or surgery within 3 months immediately prior to enrolment for this trial * pre-existing ocular irritation that would preclude contact lens fitting * currently enrolled in an ophthalmic clinical trial * evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of the accessory solutions, as determined by the investigator * any use of medications for which contact lens wear could be contradicted, as determined by the investigator * current extended-wear users (sleep-in overnight) * current monovision lens wearers * current wearers of multifocal contact lenses * current wearers of toric contact lenses (front surface design) * current wearers of astigmatic contact lenses (posterior surface design) * has a reported "strong" comfort or vision preference between each eye with their habitual rgp lenses * unacceptable fit of habitual lenses * pregnant women and nursing mothers * best-corrected visual acuity worse than 6/9 (logmar: +0.20; snellen decimal: 0.63)
anti-vegfr vaccine therapy in treating patients with neovascular maculopathy

Conditions: Neovascular Maculopathy; Age Related Macular Degeneration

Summary: the purpose of this study is to evaluate the safety and time to progression of hla-a\*2402 or a\*0201 restricted epitope peptides vegfr1 and vegfr2 emulsified with montanide isa 51 in patients with neovascular maculopathy, including age related macular degeneration

vegf receptor 1 and 2 are essential targets to pathogenic angiogenesis, and we identified that peptides derived from these receptors significantly induce the effective tumor specific ctl response in vitro and vivo. according to these findings, in this trial, we evaluate the safety, immunological and clinical response of those peptides. patients will be vaccinated once a week for 12 weeks. on each vaccination day, vegfr1 peptide (1mg) and vegfr2 peptide (1mg) mixed with montanide isa 51 will be administered by subcutaneous injection. in the study, our primary aim is to evaluate the safety and tolerability of these peptide vaccine. the second aim is evaluate the immunological and clinical response of this vaccine therapy.

Eligibility criteria:
inclusion criteria: * neovascular maculopathy including age related macular degeneration. * resistant against pdt or anti vegf therapy or patient disagree with these therapies. * with hla-a\*2402 or a\*0201 exclusion criteria: * pregnancy(woman of childbearing potential:refusal or inability to use effective means of contraception) breastfeeding active or uncontrolled infection unhealed external wound concurrent treatment with steroids or immunosuppressing agent uncontrolled brain and/or intraspinal lesion(s) decision of unsuitableness by principal investigator or physician-in-charge
comparison of the pentax aws® with the macintosh laryngoscopic intubation in obstructive sleep apnea syndrome patients

Conditions: Sleep Apnea, Obstructive

Summary: the pentax-aws_ system (aws; pentax corporation, tokyo, japan) is a new rigid indirect laryngoscope which has an integrated tube passage function. pentax-aws improved the laryngeal view and facilitated tracheal intubation in patients with restricted neck motion. the purpose of this clinical trial was to evaluate the relative efficacy of the aws laryngoscopes when used by experienced anesthetists in obstructive sleep apnea syndrome (osas) patients and to compare its performance with the macintosh laryngoscope.

the occurrence of difficult intubation in osas patients is higher than in age and sex matched control patients. the pentax-aws_ system (aws; pentax corporation, tokyo, japan) is a new rigid indirect laryngoscope which has an integrated tube passage function. several studies reported that pentax-aws improved the laryngeal view and guide also facilitated rapid, easy and reliable tracheal intubation in patients undergoing elective surgery. the purpose of this clinical trial was to evaluate the relative efficacy of the aws laryngoscopes when used by experienced anesthetists in osas patients and to compare its performance with the macintosh laryngoscope. the investigators hypothesized that, in comparison with the macintosh, aws would reduce intubation difficulty, as measured by the intubation difficulty scale (ids) score.

Eligibility criteria:
inclusion criteria: * asa physical status 1-3 patients, * aged 20years or older, * undergoing uvulopalatopharyngoplasty(uppp) surgery under general anesthesia for a polysomnography-confirmed diagnosis of osas. exclusion criteria: * unstable teeth or mouth opening of \< 18mm * patients with any pathology of the neck, * upper respiratory tract or upper alimentary tracts, * risk of pulmonary aspiration of gastric contents, * a history of relevant drug allergy.

Keywords: sleep apnea, obstructive intubation
tissue monitoring during endovascular intervention

Conditions: Peripheral Arterial Disease; Peripheral Artery Disease; Arterial Occlusive Diseases

Summary: tissue perfusion assessment is key to more accurate measurement of foot ischemia, which is in turn an important factor in appropriate treatment decisions. in practice though, tissue perfusion measurements are not routinely undertaken as few practical solutions exist that are easy to use and fit in everyday clinical practice. pedra has developed a novel, easy to use, non-invasive device that can be used in practice to better inform treatment decisions.

tissue perfusion assessment is key to more accurate measurement of foot ischemia, which is in turn an important factor in appropriate treatment decisions. in practice though, tissue perfusion measurements are not routinely undertaken as few practical solutions exist that are easy to use and fit in everyday clinical practice. pedra has developed a novel, easy to use, non-invasive device that can be used in practice to better inform treatment decisions. this is a feasibility study to demonstrate the ability of the xauron system to track tissue perfusion changes in patients undergoing endovascular intervention for the treatment of peripheral artery disease (pad). the findings of this study are for research purposes and will also be used to help with the future education of physicians about the potential use of the xauron system. in addition, this early pilot data will be used to help power larger, more definitive studies relating to the intra-procedural use of the xauron system.

Eligibility criteria:
inclusion criteria: * the subject is undergoing endovascular intervention for the management of their pad. * the subject is between 40 and 90 years of age. * documented lower limb arterial occlusive or stenotic disease (using ankle-brachial index / pulse volume recording, duplex ultrasound or ct angiogram) within the last 8 weeks. * in the opinion of the investigator, the subject is willing and able to comply with the protocol and complete all protocol assessments. * subject has been informed of the nature of the study, agrees to its provisions and has willingly provided written informed consent, approved by the appropriate institutional review board (irb) exclusion criteria: * subjects on an investigational drug or being treated with an investigational therapeutic device, within 30 days of the study visit, that in the view of the investigator might interfere with the study outcomes. * presence of a condition that the investigator considers will compromise the subject's ability to participate in the study. * subjects on renal replacement therapy * signs of active infection causing localized inflammation on the plantar or dorsal surfaces of the foot. * diabetic subjects with a charcot neuropathic osteoarthropathy * lack of intact skin, or pathological skin conditions, at the proposed sensor pad positions that may impair or prevent the adherence of medical adhesives in general.
hybrid characterization of driver sites during atrial fibrillation and sinus rhythm

Conditions: Persistent Atrial Fibrillation

Summary: the primary objective of this study is twofold, first we aim to identify rotors in atrial fibrillation (af) and analyze their relationship with the left atrium-left atrial appendage (la-laa) connections. secondly, we will analyze the areas harboring rotors in sr to define the characteristics that describe the presence of rotors.

the primary objective of this study is the identification of la and laa areas driving atrial fibrillation to study their relationship with laa-la connections and sinus rhythm (sr) analysis using the cartofinder and coherent algorithms that carto v7 offers. the cartofinder tool will be able to determine the activation patterns of reentrant drivers (rotors) in the la and laa in af. the characterization of areas harboring rotors could be performed with the coherent tool provided by carto v7 to determine the activation patterns during reentrant rhythms, and after sinus rhythm restoration it could be used to assess the conduction patterns at la-laa connections and driver sites identified with cartofinder.

Eligibility criteria:
inclusion criteria: * persistent atrial fibrillation * the patient has signed the informed consent form * no laa previous ablation procedure * no valvular disease * lvef ≥ 35% prior to recruitment * age ≥ 18 years exclusion criteria: * lvef \< 35 % * hyperthyroidism or hypothyroidism * mental or physical illness incapacitation * planned cardiac procedure * non-controlled hypertension * terminal renal failure or dialysis * class iv of the nyha * age ≥ 75 years * life expectancy \< 2 years * atrioventricular block * pregnancy

Keywords: atrial fibrillation catheter ablation rotors
pre-emptive abdominal aortic aneurysm sac embolization during evar

Conditions: Abdominal Aortic Aneurysm Without Rupture

Summary: pre-emptive abdominal aortic aneurysm sac embolization during endovascular abdominal aortic repair for infrarenal abdominal aortic aneurysm - randomized study

in all 124 patients will be included, 62 in each group. the first group (62 patients) with pre-emptive aaa sac embolization during evar and the control group consisted of 62 patients without pre-emptive aaa sac embolization. the primary goal is to investigate aaa shrinkage/diameter changes in the pre-emptive embolization group compared with the non-embolization group. further, to investigate all endoleaks and secondary interventions during the follow-up and any difference between groups and correlation if any with pre-emptive embolization. demographic, comorbidities, antiplatelet and anticoagulation drugs, aaa characteristics, patent lumbal and inferior mesenteric artery, intervention characteristics and follow-up data will be recorded and analysed.

Eligibility criteria:
inclusion criteria: * patient with 55mm (male) or 50 mm (female) aaa, available for evar * \> 18 year old exclusion criteria: * not accept to participate * ruptured aaa * outside for instruction for the use evar

Keywords: aaa embolization endoleak sac regression
effect of black tea on vascular function

Conditions: Vascular Function

Summary: epidemiological studies indicate that regular consumption of three cups of black tea per day reduces the risk of stroke or myocardial infarction. in a number of previous nutrition intervention studies tea has been shown to improve vascular function as assessed by flow mediated dilation (fmd).

the current study tests a specific black tea extract against a placebo in population that has previously show to be sensitive to the effect of black tea on flow mediated dilation. a tea extract that has previously been shown to improve fmd is included as the positive control.

Eligibility criteria:
inclusion criteria: * apparently healthy male volunteers with no history of cardiovascular disease * having body mass index (bmi) of between 18.0 and 30.0 kg/m2 (inclusive) * non-smokers (\> 2 years) * non-tea drinkers (less or equal 1 cup/week) * limited alcohol intake (less or equal 21 units/week) * systolic blood pressure less or equal 160 mmhg and/or diastolic blood pressure less or equal 100 mmhg at screening * brachial artery can be imaged using ultrasound and at screening fmd value is within the expected range as judged by the pi * judged to be in good health on the basis of medical history, physical examination and routine laboratory tests (total cholesterol, hdl cholesterol, ldl cholesterol, triglycerides, glucose, highly sensitive c-reactive protein).

Keywords: vascular function flow mediated dilation tea
the diagnostic accuracy of the clinical examination

Conditions: Musculoskeletal Pain; Musculoskeletal Injury

Summary: this study examines the diagnostic accuracy of the clinical examination as compared to mri findings

when patients get musculoskeletal pain and seek care, the healthcare professional performs a detailed clinical examination to determine a diagnosis and determine a plan of care which often includes imaging. there are only a few studies that have looked at the accuracy of the clinical examination in a primary care setting, most studies having been performed in a specialty practice treating orthopedic or sports injuries. in these practices, surgery has become and remains the gold standard. however, in primary care, often imaging like magnetic resonance imaging (mri) has become the the criterion standard. this double blind study will compare the diagnosis reached by clinical exam to the results found on mri. in addition, the examining clinician will report their recommended plan of care after the examination.

Eligibility criteria:
inclusion criteria: * subjects 18-80 years old with musculoskeletal pain/dysfunction exclusion criteria: * outside the inclusion age range, pain/dysfunction of other than musculoskeletal origin, those in whom mri is contraindicated for example, with shrapnel in the body

Keywords: diagnostic accuracy clinical examination neck back shoulder hip knee foot ankle stress fracture
periodontitis and coronary heart disease

Conditions: Periodontitis; Coronary Heart Disease

Summary: "atherosclerosis is an inflammatory disease". the hypothesis of an infectious burden as trigger or initiator of the inflammatory process in atherosclerosis has been extensively discussed in the past years. one part of this discussion is focused on the infectious agents responsible for periodontitis. several studies have found an association of periodontitis and/or bacteria related to this disease and atherosclerosis. however, a study focussing on the prognostic relevance of these factors is missing. the hypothesis of this study is that periodontitis is a prognostic relevant risk factor for patients with angiographically proven coronary heart disease. furthermore, the infectious pathogen burden by pcr-detection of periodontal pathogens will be evaluated as a prognostic factor. 960 consecutive patients with angiographically proven coronary heart disease will be included in this study. after inclusion of patients an extensive periodontal examination including pcr-sampling for 11 bacteria (porphyromonas gingivitis, actinobacillus actinomycetemcomitans, and others) will be performed. after 12 months patient will be follow up for any major adverse events (cardiovascular death, myocardial infarction, stroke). if this study will find a relation of periodontitis or its microbiological agents to cardiovascular outcome of patients with coronary heart disease, further studies are necessary to investigate potential therapeutic consequences for patients with chd and periodontitis.


Eligibility criteria:
inclusion criteria: * age \>18 years * coronary heart disease as defined by previous or current detection of 50% stenosis of a main coronary artery by coronary angiography or previous or current percutaneous coronary intervention (pci) or previous or current coronary artery bypass surgery (cabg) exclusion criteria: * inability to give written informed consent * periodontal treatment and/or antibiotic therapy during the last 6 months * pregnancy * current alcohol or drug abuse, or psychological reasons that make study participation impractical * drugs which are potential causal for gingival hyperplasia (hydantoin, nifedipine, cyclosporin a, and other)

Keywords: periodontitis and coronary heart disease
retrospective study to assess real-life use of the long acting gnrh agonist as prostate cancer treatment

Conditions: Prostate Cancer

Summary: it is a retrospective review of the electronic medical record of patients on long-acting triptorelin in hong kong.

prostate cancer is the second most prevalent cancer in men worldwide. analogues of natural gonadotrophin releasing hormone (gnrh) are currently available in clinical practice to induce castration in subjects with prostate cancer. while 6 month formulation of triptorelin has been approved since 2018 for controlling tumor growth in subjects with prostate cancer living in hong kong, to date, there are no published clinical data regarding the use and efficacy of the 6 month formulation in chinese subjects with chinese heritage. to better understand the real-world experience of long-acting gnrh agonist, there is an unmet need for a retrospective, noninterventional review to collect data regarding the use of the long-acting formulation gnrh in clinical practice as a treatment for prostate cancer. the purpose of this study is to collect data on healthcare characteristics and the treatment patterns in the real-world setting, as well as to understand the profile of the subject population using long-acting formulation gnrh agonist.

Eligibility criteria:
inclusion criteria: * patients of chinese heritage * prostate cancer patients with the following disease status: * high-risk prostate cancer having hormonal therapy as neoadjuvant / adjuvant treatment for prostatectomy or radiotherapy; or * advanced / metastatic prostate cancer treated with long-term hormonal therapy; or * after primary therapy (surgery or radiotherapy) with biochemical recurrence; or * castration-resistant prostate cancer status * received at least one dose of 6-month gonadotropin-releasing hormone agonist triptorelin formulation * having at least 6 months of follow-up after administration of the 3-month to 6-month gonadotropin-releasing hormone agonist triptorelin exclusion criteria: * nil
effects of chinese medicine on patients with severe acute exacerbation of copd

Conditions: Acute Exacerbation Of Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study was to evaluate the effects of chinese medicine on patients with severe aecopd, and to provide a basis for the establishment of integrated cm and western medicine diagnosis and treatment scheme for patients with severe aecopd.

aiming at the key problems such as the lack of high-quality clinical research evidence of chinese medicine in the prevention and treatment of severe aecopd, this study adopted a multi-center, randomized, double-blind, placebo-controlled parallel trial design, taking 468 severe aecopd patients as the research object, to evaluate the clinical efficacy and safety of chinese medicine combined with western medicine in the treatment of severe aecopd. to establish an integrated chinese and western medicine diagnosis and treatment plan to reduce the treatment failure rate of severe aecopd patients, and to form high-level evidence-based evidence.

Eligibility criteria:
inclusion criteria: 1. patients with severe aecopd.; 2. age 40-80 years old; 3. chinese medicine diagnosis consistent with external cold and internal drink syndrome, or phlegm-heat congestion of the lungs syndrome, or phlegm turbidity obstruction of the lungs syndrome; 4. voluntarily accept the treatment and sign the informed consent form; exclusion criteria: 1. pregnant and lactating women. 2. delirious, dementia, various mental patients and other people who cannot communicate normally. 3. patients with severe cardiac insufficiency (nyha grade iv), malignant arrhythmia and hemodynamic instability. 4. patients with acute respiratory failure who require tracheal intubation or invasive mechanical ventilation. 5. complicated with bronchiectasis, active tuberculosis, severe liver and kidney disease (severe liver disease refers to cirrhosis, portal hypertension and varicose vein bleeding, etc., serious kidney disease including dialysis, kidney transplantation, etc.), pneumonia, hiv infection or immunosuppressive state, advanced malignant tumor, etc. 6. long-term bedridden patients for various reasons. 7. out-of-hospital treatment for more than 3 days. 8. participate in other drug clinical investigators within 1 month before enrollment. 9. allergic to therapeutic drugs.
safety and efficacy of licaminlimab ophthalmic solution for the treatment of dry eye disease

Conditions: Dry Eye Disease

Summary: the goal of this clinical trial is to learn about licaminlimab (ocs-02) in the treatment of dry eye disease. the main question it aims to answer is if licaminlimab ophthalmic solution is more effective than vehicle in treating signs of dry eye disease.

this is a phase 2b, multicenter, randomized, double-masked, active-control study designed to evaluate the efficacy and safety of licaminlimab for the treatment of signs and symptoms of dry eye disease.

Eligibility criteria:
inclusion criteria: * be at least 18 years of age. * provide written informed consent. * be willing and able to comply with all study procedures. * have a history of dry eye disease for at least 6 months prior to visit 1. exclusion criteria: * have any clinically significant slit-lamp findings at least one eye at visit 1 that may include active blepharitis, meibomian gland dysfunction, lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters. * be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation in at least one eye at visit 1 or visit 2. * have worn contact lenses within 7 days of visit 1 or anticipate using contact lenses in the study eye during the study. * additional inclusion/exclusion criteria apply.

Keywords: ophthalmology topical ophthalmic solution eye drop ded
audit of international intraoperative hemotherapy and blood loss documentation

Conditions: Patient Safety; Patient Blood Management

Summary: the investigator hypotheses anesthetic records do not contain detailed information on hemotherapy and blood loss estimation. therefore anesthetic records will be collected from different institutions and analyzed for items concerning hemotherapy contained.

the anaesthetic record is the primary way anesthetists document and communicate information regarding hemotherapy. records vary in content and design. several organizations published recommendations, but perioperative hemotherapy is not sufficiently detailed for the purpose. anesthetic records will be analyzed for 20 defined hemotherapy and monitoring items by two independent investigators. disagreements will be resolved by a the principle investigator.

Eligibility criteria:
inclusion criteria: * anesthetic records exclusion criteria: * incomplete records